evaluation on safety and effectiveness of the an all-inside, all-suture meniscal repair device

Conditions: Meniscal Tears

Summary: this study is a prospective, multi-center, randomized controlled pre-market clinical trial in china to evaluate the safety and efficacy of the juggerstitch™ meniscal repair device for arthroscopic meniscal repair. the study aims to compare the clinical outcomes of the juggerstitch™ device with the fast-fix 360 meniscal repair system in patients with meniscal tears. the primary endpoint is the lysholm knee score at 6 months postoperatively, and secondary endpoints include immediate device success rate, tegner activity score, visual analogue scale (vas) score for pain, meniscal healing evaluated by mri, and device-related adverse event rate. the study will enroll 94 subjects across 5 clinical sites.

1. purpose of the study the purpose of this study is to evaluate the safety and efficacy of the juggerstitch™ meniscal repair device for arthroscopic meniscal repair in patients with meniscal tears. the study will compare the clinical outcomes of the juggerstitch™ device with the fast-fix 360 meniscal repair system, a well-established device for meniscal repair. 2. study design and methodology this is a prospective, multi-center, randomized controlled pre-market clinical trial. the study will involve 5 clinical sites and will enroll a total of 94 subjects. subjects will be randomly assigned to either the investigational group (juggerstitch™ device) or the control group (fast-fix 360 device). the primary endpoint is the lysholm knee score at 6 months postoperatively, and secondary endpoints include immediate device success rate, tegner activity score, vas score for pain, meniscal healing evaluated by mri, and device-related adverse event rate. 3. inclusion and exclusion criteria 1) inclusion criteria: age between 18 and 60 years; scheduled for meniscal repair with a vertical longitudinal full-thickness tear (e.g., bucket-handle) in the red-red and red-white zones; able to understand all risks and benefits described in the informed consent form and willing to comply with the rehabilitation and follow-up visits specified in the clinical trial protocol. 2) exclusion criteria: meniscal tears in the avascular zone of the meniscus; meniscal tears not suitable for repair due to the degree of damage (marked irregularity and complex tearing) to the meniscus body, including degenerative, radial, horizontal cleavage, flap, and root tears; multiple ligament injuries of the affected knee joint; adhesion of the affected knee joint; planned intraoperative or postoperative intra-articular injection; articular surface cartilage injury of the targeted knee assessed by the international cartilage repair society (icrs) is grade 3-4; kellgren-lawrence grades of documented radiographic evidence of osteoarthritis (oa) in the affected knee is ≥iii; instability or valgus/varus deformity (\>5°) of the affected knee; acute or chronic, local or systemic infections; metabolic diseases; abnormal liver and kidney function (creatinine 3 times higher than the upper limit of normal value or alanine aminotransferase or aspartate aminotransferase 3 times higher than the upper limit of normal value) before operation; history of operation in the affected knee; acute myocardial infarction or stroke occurred within 6 months before operation; known allergy to any material (polyethylene, polypropylene, polyester, polyetheretherketone) of the implants; pregnant or known to be pregnant; other circumstances that the researchers believe may affect the efficacy and safety evaluation of the investigated medical devices; currently participating in other clinical trials; 4. surgical procedure the surgical procedure will involve arthroscopic exploration and repair of the meniscal tear using either the juggerstitch™ device or the fast-fix 360 device. the specific steps for each device will be followed according to the manufacturer's instructions and the surgeon's standard operating procedures. postoperative rehabilitation and follow-up: postoperative rehabilitation will include the use of an elastic bandage, appropriate massage to prevent blood clots, and guidance on quadriceps isometric contraction and straight leg-raising training. subjects will be followed up at 3 months, 6 months, and 12 months postoperatively. at each follow-up visit, the lysholm knee score, tegner activity score, and vas score for pain will be recorded. mri of the knee joint will be performed at 6 months and 12 months postoperatively to evaluate meniscal healing. assessment of efficacy and safety: efficacy will be assessed using the lysholm knee score, tegner activity score, and vas score for pain. safety will be assessed by monitoring and recording adverse events, including device-related adverse events, during the follow-up period. statistical considerations: the sample size calculation is based on the difference in lysholm knee score at 6 months postoperatively. a total of 94 subjects will be enrolled, with 47 subjects in each group. the primary endpoint will be analyzed using a covariance analysis model, and the secondary endpoints will be analyzed using appropriate statistical methods.

Eligibility criteria:
inclusion criteria: * age between 18 and 60 years * scheduled for meniscal repair with a vertical longitudinal full-thickness tear (e.g., bucket-handle) in the red-red and red-white zones * able to understand all risks and benefits described in the informed consent form and willing to comply with the rehabilitation and follow-up visits specified in the clinical trial protocol exclusion criteria: * meniscal tears in the avascular zone of the meniscus * meniscal tears not suitable for repair due to the degree of damage (marked irregularity and complex tearing) to the meniscus body, including degenerative, radial, horizontal cleavage, flap, and root tears * multiple ligament injuries of the affected knee joint * adhesion of the affected knee joint * planned intraoperative or postoperative intra-articular injection * articular surface cartilage injury of the targeted knee assessed by the - international cartilage repair society (icrs) is grade 3-4 kellgren-lawrence grades of documented radiographic evidence of osteoarthritis (oa) in the affected knee is ≥iii * instability or valgus/varus deformity (\>5°) of the affected knee * acute or chronic, local or systemic infections * metabolic diseases * abnormal liver and kidney function (creatinine 3 times higher than the upper limit of normal value or alanine aminotransferase or aspartate aminotransferase 3 times higher than the upper limit of normal value) before operation * history of operation in the affected knee * acute myocardial infarction or stroke occurred within 6 months before operation * known allergy to any material (polyethylene, polypropylene, polyester, polyetheretherketone) of the implants * pregnant or known to be pregnant * other circumstances that the researchers believe may affect the efficacy and safety evaluation of the investigated medical devices * currently participating in other clinical trials

Keywords: meniscal repair arthroscopic surgery juggerstitch™ meniscal repair device